Vascular closure methods and apparatuses

ABSTRACT

A vascular closure device comprised of a sheath-delivered expandable, umbrella-like device with structural radial members with terminal and non-terminal hooks that engage the vessel wall. Unlike other vascular closure umbrella-type devices that effect closure by opening of the umbrella to cover an opening, the present invention effects closure of the aperture with closure of the umbrella. The closure can be maintained by a retainer lock that slides down the members, causing contraction, bringing the members into a compressed configuration (e.g., a parallel orientation of linear members) and the wound edges together, permitting immediate vascular closure and healing of the blood vessel. The device can be delivered and recovered by an intravascular sheath.

BACKGROUND

The present invention relates to methods and apparatuses for closingpunctures and apertures in human and animal tissue and to methods andapparatuses for inserting such an apparatus into such tissue to performsuch closure functions.

During angiography and related procedures, catheters are insertedthrough an incision or puncture in the skin and underlying tissues toaccess an artery or vein, typically in the groin, neck, or subclavianareas of a patient. The catheter can be inserted through a puncture inthe blood vessel and guided to the desired site to performinterventional procedures such as angiography, angioplasty, plaqueremoval, and infusion of a therapeutic substance. After the procedure iscompleted and the catheter is removed from the patient, the access holemust be closed to prevent massive hemorrhage. This is conventionallyachieved by applying pressure over the blood vessel manually and then byapplying a pressure bandage, compressive weight, or clamp device. Withconventional methods, the rate of post-puncture hemorrhage is high,which causes considerable complications. This complication isexacerbated by the concomitant use of anticoagulant medications such asheparin or warfarin and by antiplatelet drugs, which are commonly usedto treat vascular disease.

Sutures have been used to close access puncture wounds in blood vessels.U.S. Pat. No. 5,613,974 describes a device and method for applyingsutures to a vascular puncture. US2004/0093027A1 describes barbedsuture-like material that apposes the puncture site. US 2005/0121042 A1describes a device and method for applying suture to a vascularpuncture. Difficulties with these methods include the large number ofsteps necessary to deploy the needles, capture the suture, withdraw thesuture, tie the knot, and cut the suture. In addition, the hole in theblood vessel is often widened by insertion of the instrument, and thesuture remains intravascularly on the endothelial surface, and thus canbe a nidus for thrombus or intravascular mural hyperplasia with laterspontaneous and catastrophic closure of the vessel.

Extravascular plugs have also been proposed for closure of vascularpunctures. U.S. Pat. No. 5,254,105 and U.S. Pat. No. 5,330,445 describean extravascular plug which is slid down the external surface of thecatheter or introducer and is placed into the puncture site in thismanner. U.S. Pat. No. 5,643,318 relates to a similar device that has itsown vessel locator device. US22022822A1 and US2004/0158287A1 describe anextravascular plug that is delivered with a specialized system.US24215232A1 describes an extravascular plug with an intravascularanchor set with a sheath with a detection port. US2005/0085855A1describes an extravascular collagen plug, held in place with anintravascular anchor, and a device that locks over a piece of suture.U.S. Pat. No. 5,906,631 describes a plug made of hydrophilic material.U.S. Pat. No. 6,126,675 describes an intravascular anchor and abioabsorble extravascular plug. U.S. Pat. No. 6,623,509 describes abioabsorbable plug. U.S. Pat. No. 6,296,657 and U.S. Pat. No. 6,743,195describe an inflatable balloon that puts pressure on the puncture site.U.S. Pat. No. 6,569,185 describes an injectable vascular plug. U.S. Pat.No. 6,663,655 describes a plug that screws in the puncture tract.US2004/0143290 A1 describes a combination of an intraluminal balloon andinjectable sealant. Disadvantages to these methods are related to thehigh likelihood of thrombosis associated with the intravascular plug oranchor, and the presence of collagen or other bioabsorble materialswhich cause inflammation, activate the clotting cascade, and increasethe likelihood of thrombosis, which, in an arterial system, iscatastrophic.

Vascular patches have also been used for repairing blood vessels, butusually only for large areas of damage. U.S. Pat. No. 5,100,422describes a vascular patch that is sutured to the external surface ofthe damaged blood vessel. U.S. Pat. No. 5,100,422 describes a vascularpatch achieved by instilled adhesives and the device for doing such.These are generally impractical for catheter-based methods. U.S. Pat.No. 6,248,124 and U.S. Pat. No. 5,507,744 describe devices and methodsthat use electrocautery for sealing vascular punctures. This alsorequires a complicated device, and perforation and thrombosis are veryreal possibilities.

Vascular clips or staples delivered through a catheter device have alsobeen proposed. These devices have penetrating members that bring theedges of the tissue together. U.S. Pat. No. 6,695,867 describes a clipor staple that is delivered by a specialized device. U.S. Pat. No.6,749,622 describes a number of different clips with sharpened barbs orends that include both intra- and extravascular portions, made of metalwith memory characteristics. U.S. Pat. No. 5,861,005 describes anarterial staple that is delivered with a specialized device. U.S. Pat.No. 5,919,207 describes a stapling system based on long hooked wiresthat appose the surfaces, with a small staple gun to close the lesion.U.S. Pat. No. 6,022,372 describes a similar staple gun. U.S. Pat. No.6,296,657, U.S. Pat. No. 6,663,655, and U.S. Pat. No. 6,749,621 describea clip that is external to the vessel, but clips the two sides of thepuncture together, and a device for achieving such. U.S. Pat. No.5,782,861 and U.S. Pat. No. 5,964,782 describe clip devices composed oftwo or more prongs or hooks that, depending on the direction of theprongs, can clip together the puncture site from the intra- orextravascular position, through the use of a collar which forces theprongs together or other mechanisms. These clip devices are composed ofthick semi-rigid material, and can be placed only with a specializedinstruments, and because of the rigidity have great potential to injureor cut the blood vessel. Disadvantages of these clip devices in generalinclude difficulty in retrieving the device if misplaced, excessivemanipulation required, the thickness of the clip material which tends tocut or shear the blood vessel, the large forces that must be used tocurve the staples and fix the clips, the increased possibility oftearing the blood vessel, and the general lack of control of the forcesbeing applied to the blood vessel.

Accordingly, there is a need for methods and apparatuses that aresuitable for closure of vascular punctures or other openings, and thatdo not suffer from the drawbacks of conventional approaches.

SUMMARY OF THE INVENTION

The present invention provides methods and apparatuses that are suitablefor closure of vascular punctures or other openings, and that do notsuffer from the drawbacks of conventional approaches.

The present invention comprises a tissue closure device, comprising aplurality of tissue engagement elements, mounted with each other suchthat in a first compressed configuration the tissue engagement elementscan pass through a tissue opening to be closed, and such that in asecond compressed configuration the tissue engagement elements bring theedges of the opening into apposition, and such that in an expandedconfiguration the tissue engagement elements span the opening, whereinthe tissue engagement elements engage the tissue in the compressedconfiguration and in the expanded configuration.

The present invention also comprises methods for closing tissueopenings, comprising passing a device while in the first compressedcondition through a sheath that penetrates the proximal surface of thetissue; expelling the device from the sheath into space beyond theproximal surface of the tissue such that the device assumes the expandedconfiguration; c) manipulating the device such that the tissueengagement elements engage the tissue; d) causing the device to assumethe second compressed configuration, bringing the edges of the openinginto apposition.

The present invention can provide a catheter-delivered umbrella-likedevice comprising fine, strong, flexible material that after deliveryexpands in a blood vessel so that the individual members extend beyondthe catheter edges and/or puncture dimensions. The device can be viewedas analagous in structure and design as contemporary expandable vascularfilters and closure umbrellas, although its purpose and function iscompletely different. As the catheter is withdrawn, the device is pulledagainst the interior of the blood vessel and the hooks or graspingdevices on the ends of the members seize the interior of the vesselwall. Because of the very fine and flexible nature of the members andtheir multiplicity, there is minimal shear force applied to the bloodvessel. While pulling on the retaining suture to keep the device againstthe blood vessel, a retaining lock is then advanced distally starting atthe proximal portion of the members, which causes the members to firstangle the device into a conical shape and then force the individualmembers together in a linear parallel direction, which because themembers are engaged with the vessel wall, brings the edges of thepunctured tissue together into apposition. The retainer lock is thenlocked onto the parallel members and can keep tension on the woundexternally, and can prevent intravascular migration of the device. Ifthere is no blood leakage through the closure and the device is properlypositioned and stable, then the guidewire can be removed and theretaining suture or string loop cut, resulting is complete and rapidclosure, which can then heal.

Since this device brings the puncture edges together, there is trueblood vessel healing with little endothelial disruption, reducing thechances of thrombosis or intimal hyperplasia. The device can be suppliedin different diameters (e.g., french) to accommodate different sizes ofcatheters and different sizes of puncture holes.

The present invention can comprise a device with umbrella-likestructure, which can be viewed as analogous to the various designs ofintravascular filters and aperture seals, which are delivered in afolded or compressed form, and then expanded to their filter shapes.U.S. Pat. No. 4,969,891 describes a self-expanding removable filterdevice that is placed with a sheath. U.S. Pat. No. 5,634,942 and U.S.Pat. No. 5,634,942 describe a similar device but with two sets of armswhich protrude in opposite directions. U.S. Pat. No. 6,241,746 B1 is asimilar version that can be converted to a vascular stent. U.S. Pat. No.6,361,546 is a version with a central guidewire lumen. U.S. Pat. No.6,428,559 describes a variable-diameter vascular filter system. U.S.Pat. No. 6,485,501 B1 also describes a filter with a guidewire. US2003/0208227 describes different construction configurations of afilter. US 2004/0087999 A1 reveals various types of structures to retainthe filter in the vessel. U.S. Pat. No. 5,709,707 describes a typicalumbrella-type closure device used to close apertures. Each of thepreceding patents and applications are incorporated herein by reference.The present device, analogous to many of the vascular filters andumbrella closure devices noted above, is both expandable like anumbrella and retrievable if it had to be retrieved because ofmisplacement. Unlike previous umbrella closure devices, the presentdevice engages the tissue in both the expanded and compressedconfigurations, and functions by bringing tissue edges into appositionrather than by providing a patch that covers the opening. In addition,although the embodiments shown here generally have linear members, thesemembers, like the structure of the intravascular filters andumbrella-type devices, need not be strictly linear, but can assume anumber of complex geometrical shapes and structural patterns.

The present device, like some contemporary vascular filters, can utilizean expanding material, preferably with memory characteristics, thatopens up spontaneously within the blood vessel. The device also, likesome contemporary filters, can have tissue hooks or penetrators, inorder to seize the vessel wall and stabilize the device. However, unlikean umbrella-style vascular filter, the device uses this opening-closingquality to seize the edges of the puncture site, and close them,resulting in a complete vascular closure. Although the device can beviewed as analogous to some contemporary self-expanding and retractablevascular filters, it is unlike them in that in certain embodiments ithas a retaining lock to force the umbrella to reassume its folded state.

DESCRIPTION OF THE FIGURES

The invention is explained by using embodiment examples andcorresponding drawings, which are incorporated into and form part of thespecification.

FIG. 1 (a,b) is a schematic depiction of a vascular closure appositiondevice according to the present invention.

FIG. 2(a,b) is a schematic depiction of a vascular closure appositiondevice according to the present invention.

FIG. 3(a,b) is a schematic depiction of a vascular closure appositiondevice with a guidewire lumen, according to the present invention.

FIG. 4 is a schematic depiction of a vascular closure apposition deviceaccording to the present invention.

FIG. 5 is a schematic depiction of a vascular closure apposition deviceaccording to the present invention.

FIG. 6(a,b,c) are schematic depictions of example embodiments ofvascular closure apposition devices according to the present invention.

FIG. 7(a,b,c,d,e,f) is a schematic illustration of a method of closing avascular opening according to the present invention.

FIG. 8(a,b,c,d) is a schematic depiction of a double-action vascularclosure apposition device according to the present invention.

FIG. 9(a,b,c) is a schematic depiction of a double-action vascularclosure apposition device according to the present invention.

DETAILED DESCRIPTION

The present invention provides apparatuses and methods for closing avascular puncture wound or any tissue aperture, for example thoseresulting from the insertion of a vascular catheter or surgicalinstrument, trauma or disease. The present invention embraces bothapparatus and method aspects of devices for closing a vascular puncture,and the methods for delivering such a device. The present device can beclosed in the delivery system (catheter or sheath) and when discharged,be open in the blood vessel. In some embodiments, at least a portion ofthe device can be formed of a memory metal or similar material, as iscurrently done in vascular filters. The stress free state corresponds tothe state at which the apparatus has opened in a blood vessel, and thestressed state in the catheter and when a retaining lock is put intoposition. Example embodiments of tissue closure apposition devicesaccording to the present invention are shown in FIGS. 1, 2, 3, 4, 5, 6,and 8. The descriptions refer to “vessels” for convenience; the presentinvention is applicable to facilitate closure of various types of tissueopenings.

FIG. 1 (a,b) is a lateral view of a vascular closure appositionumbrella. A plurality of members 101 are disposed substantially radiallyabout a central junction 103. Each of the members 101 comprise a tissuehook 102, in the figure a double hook. The central junction 103 isadapted to engage a closed loop of string or suture 104. The hooks 102engage the tissue, and are brought and maintained together by operationof a retaining lock 105. In FIG. 1 b, the device is shown in a closedposition, where the central junction 103 has passed through theretaining lock 105.

The vascular closure apposition umbrella of FIG. 1(a,b) comprises 2 ormore members 101 placed in apposition to each other, shown in the figureas disposed substantially radially. The members 101 in the figure areshown as straight wires, but can be curved or have a wave structure orother design, for example a design to engage a retaining lock. Themembers are flexible for manipulation in tissue and delivery, yet rigidenough when extended to push the tissue engagement structures againstthe vessel wall. The tissue engagement structures 102 in this examplecomprise double hooks, allowing engagement of the tissue in 102different directions simultaneously. The tissue engagement structurescan also comprise multiple hooks, a single hook, or straight engagingdevices. The tissue engagement structures can be sharp in order topenetrate in one direction, but not to cut, thus, would generally nothave a cutting surface other than the point. The members join in acentral junction 103 which can be continuous with each of the members orcan be joined to the members by any suitable method. The centraljunction 103 comprises an eyelet or recovery loop in which initially aclosed loop of string or suture 104 engages. The eyelet or recovery loopcan be used to recover the device into a catheter in the event ofmisplacement. A retaining lock 105 can encourage closure of the device,and can also prevent unintended intravascular migration of the device.The retaining lock 105 is shown in the figure as a washer-like device,but can take a number of different shapes and can comprise a number ofdifferent materials. For example, the retaining lock 105 can compriseplastic, metal, or composite.

In operation, the tissue closure apposition umbrella is closed withinthe catheter or sheath, corresponding to the illustration of FIG. 1(b).Once placed within the blood vessel, the umbrella can be opened withinthe blood vessel, corresponding to the illustration of FIG. 1(a), sothat the hooks on the members engage the vessel wall. The umbrella canthen be closed with the retaining lock. As the umbrella closes with theretaining lock, the hooks hold the edges of the puncture wound and, asthey align with each other, bring the puncture wound edges inapposition. Undulations or excresences on the members or centraljunction can engage corresponding locking surfaces on the retaininglock. More specific locking devices such as angled dentates, peg andhole, and male-female locking surfaces can also be suitable. A guidewirecan go between the members in this particular embodiment without aspecific lumen for the guidewire.

FIG. 2(a,b) is a lateral view of a vascular closure apposition doubleumbrella. A plurality of members 201 are disposed substantially radiallyabout a central junction 203. Each member comprises a tissue engagementstructure 202, shown in the figure as a hook on the end of the member.The central junction can comprise a structure compatible with a stringor suture 204 to facilitate deployment and removal. A retaining lock205, in the figure an umbrella oriented opposite the umbrella formed bymembers 201, closes the device. FIG. 2(b) shows the device with theumbrella formed by members 201 closed, bringing tissue sides inapposition, and the retaining lock 205 open, maintaining the closedposition of the umbrella and providing tissue stability on the oppositeside of the vessel wall.

The radial members 201 in FIG. 2(a,b) are shown as straight, but canhave dentates or other devices compatible with engagement of theretaining lock. The string or suture 204 can be engaged with the centraljunction 203 to urge the central junction 203 through the retaining lock205, encouraging the members 201 into apposition. The retaining lock ofthe device of FIG. 2(a,b) comprises another expanding umbrella, butfacing the opposite direction. In the figure, the retaining lockumbrella has straight members with hooks on the ends. The retaining lockumbrella can also comprise a variety of configurations, including bentor curved members, members with various hooks or no hooks, web-likestructures, and film-like members. This retaining lock comprise morecomplicated structure members, as examples like many constructions ofintravascular stents and filters. The members 201 close and bring thetissue together as in FIG. 2(b); the retaining lock can provide fortissue stability in the extravascular tissues. A guidewire in thisembodiment can go between the members without a specific lumen for theguidewire.

FIG. 3(a,b) is a lateral view of a vascular closure apposition umbrellawith a guidewire lumen. The device comprises members 301 disposedsubstantially radially about a central junction 303. Each arm 301comprises a tissue engagement structure 302, in the figure shown as adouble hook on the end of the arm 301. The central junction 303comprises a columnar guidewire lumen with a recovery loop or device forengaging a closed loop of string or suture 304. A retaining lock 305that closes the device. FIG. 3(b) shows the device in a closed positionwith the retaining lock 305 engaged.

The embodiment of FIG. 3(a,b) comprises a closure apposition umbrellawith a guidewire lumen. Inclusion of a guidewire lumen can reduceinterference of the guidewire with placement of the umbrella, and allowsthe guidewire to remain in place in case the seating of the device isnot optimal and then the device must be retrieved. The device can bedelivered and placed with a guidewire in place. The apposed tissue mightclose the lumen once the guidewire is withdrawn. If desired, a softone-way flap valve (not shown) or other structure can be placed in thelumen to occlude any blood flow that might occur when the wire iswithdrawn.

FIG. 4 is a lateral view of a vascular closure apposition umbrellacomprising members 401 disposed substantially radially about a centraljunction 403, forming an overall conical shape. The members have tissueengagement structures 402, shown in the figure as hooks at the ends ofthe members 401. The members also have reversed barbs or feathers 406 toprevent intravascular migration of the device and to maintain themembers in a closed state by engaging the tissue, a retaining lock, orboth. In operation, the embodiment of FIG. 4 is similar to thosediscussed previously.

FIG. 5 is a lateral view of a vascular closure apposition umbrella. Aplurality of members 501 are disposed substantially radially about acentral junction 503. The members have tissue engagement structures 502,shown in the figure as a hook at the end of the member 502. The centraljunction 503 can have a recovery loop or device, and can engage a stringor suture 504 for delivery, placement, and recovery. A retaining lock505 can engage the members 501, the central junction 503, or both, toencourage the device to and maintain the device in a closed position. Abacking or coating 507 can be mounted with the members as a fabric, web,or film. The backing can carry, or be made of, a material that can elutedrug to prevent coagulation or to prevent endothelial hyperplasia or canbe hemostatic initially, and fill the puncture track later.

FIG. 6(a,b,c) are lateral views of example embodiments of vascularclosure apposition devices according to the present invention. In FIG.6(a), members 601 comprise elongated diamond shapes (rather than thestraight wires depicted previously), which shape can have advantages inmanufacture and in operation. The members 601 have tissue engagementstructures 602, in the figure shown as hooks mounted with members atvarious locations. In FIG. 6(b), a device having a reduced number ofmembers 611 is shown. A reduced number of members can provide for asimpler device, which can have manufacturing advantages and can besuitable for certain applications. In FIG. 6(c), members 621 comprise anon-linear geometry, and are connected by intermember struts 628. Thenon-linear geometry and intermember struts can allow specific openingand closing trajectories, and can allow optimization of forces whenopening and closing. A wide variety of specific geometries andstructures can be suitable with the present invention, as examplesincluding geometries and structures currently used in vascular filtersand stents.

FIG. 7(a,b,c,d,e,f) is a schematic illustration of a method of closing avascular opening according to the present invention. A blood vessel 701is penetrated by a sheath 702 and a guidewire 703. In FIG. 7(a), anapposition device 704, for example as described previously, is in aclosed configuration within the sheath, with the loop of string orsuture 705 engaged. In FIG. 7(b) the device 704 has been extruded fromthe sheath 702 and is in the expanded configuration within the vessel701. In FIG. 7(c), the device 704 has been positioned against the wallof the vessel 701, seating the tissue engagement structures 706 in thetissue 701. The sheath 702 has been partially removed to facilitateseating of the device. The lock can be preseated on the device (notshown) or can be placed on the device after intravascular placement ofthe device by threading the lock down the guidewire or suture onto acentral junction of the device after the device has been positioned inthe blood vessel, or positioned by a separate sheath). In FIG. 7(d), aretaining lock 707 has been advanced over the members of the appositiondevice, forcing them into the closed configuration, and bringing theedges of the opening 709 together. If no bleeding occurs, then theguidewire 703 can be removed as shown in FIG. 7(e). The loop of stringor suture 705 can be cut and removed, leaving the device 704 safelyseated and locked with the opening closed, as shown in FIG. 7(f).

Delivery of the device can be done sequentially, or can be done with adedicated device. For sequential delivery of the device, the followingsequence of steps are suitable: 1) the guidewire and sheath are inplace, 2) the device is pushed down the sheath, either next to theguidewire or with the guidewire in the lumen of the umbrella; 3) theumbrella is extruded, and then using the thread or suture, pulled tightagainst the lumen of the vessel; 4) the retaining lock is pushed downthe thread and/or guidewire, and is pushed onto the umbrella whileapplying traction (the sheath can be removed partially at this stage);5) after the retaining lock is seated, the sheath is observed forbleeding; 6) if there is no bleeding, then the sheath and guidewire areremoved. For a dedicated device, there can be a sheath with theumbrella, a pushing device to push the umbrella out (another sheath), asheath to push the retaining lock, and a thread/suture to oppose theother sheaths and to retrieve the umbrella if it is misplaced.

FIG. 8 (a,b,c,d) is a lateral view of a double-action vascular closureapposition device. In FIG. 8 a, the unassembled device is in the closedposition. The device comprises a plurality of umbrella members 801disposed substantially radially about a central junction 803. Eachumbrella member 801 can comprise a tissue hook 802, in the figure adouble hook, spaced from the junction of the member and the centraljunction 803. The central junction 803 can include a central lumen for aguidewire, and is adapted to engage a plurality of opposite facingmembers 804, which opposite facing members can optionally have hooks,tissue penetrators, or feet. The opposite facing members can comprisememory material, and be configured such that they force a retaining lock805 over the open umbrella members 1 (shown open in FIG. 8 c) forcingthem to close (as shown in FIG. 8 d).

A closed loop of string or suture (not shown) can be joined to thedevice by ways of a lumen or loop. FIG. 8 a shows the devicepreassembly. In FIG. 8 b, the device is in assembled form and in aclosed position, where the central junction 3 has passed through theretaining lock 805. In this form the double action vascular closureapposition device can reside within a delivery catheter before beingplaced in the puncture wound of a blood vessel. FIG. 8 c shows thedevice partially expelled from the sheath (not shown), where theumbrella members 801 have opened and engaged the vessel wall, analogousto the embodiments previously described. In the arrangement of FIG. 8 c,the opposite facing members 804 are retained in the sheath so that theyare prevented from forcing the lock 805 over the umbrella members 801.FIG. 8 d shows the device completely expelled from the delivery sheath,where the opposite facing members 804 are now forcing the retainingcollar or lock 805 down the umbrella members 801, causing the portionsof the umbrella members 801 with tissue engagement features (hooks inthe figure) together (i.e., closing of the umbrella). The oppositefacing members 804 are shown for ease of illustration as wire-like; theycan be configured as coiled or semi-coiled structures, strut-like,multiple angles, spring-like, curled in an opposite direction, single ormultiple members, elbow-like, or other geometrical or curvolinear shapesthat when extended are neutral to the retaining lock, but when expelled,force the lock over the umbrella members, initiating closure.

Accordingly, the double action vascular closure apposition device ofFIG. 8 is first closed, then opens, and then closes again, the secondclosure occurring spontaneously by contraction of the opposite facingmembers against the retaining lock. After the device has been deliveredand vascular closure is complete, then the guidewire can be removed.

FIG. 9 (a,b,c,) is a lateral view of a collarless double-action vascularclosure apposition device. FIG. 9 a shows the device in the closedposition. A plurality of umbrella members 901 are disposed substantiallyradially about a central junction 905, which can have a lumen for aguidewire. The central junction can comprise a retaining ring whichpermits the members to flex along their length. Each of the umbrellamembers 901 has a tissue engagement feature spaced apart from thecentral junction 905, in the figure a double hook 902. The centraljunction is adapted to engage a plurality of opposite facing members903, which optionally can have hooks, tissue penetrators, or feet 904.The opposite facing members 904 can be composed of memory material, andcan be directly joined to a corresponding umbrella member, with thememory forces in the opposite facing members dominant over the memoryforces in the umbrella members. FIG. 9 a depicts the form that thecollarless double action vascular closure apposition device would havewhile within a delivery catheter before being placed in the puncturewound of the blood vessel.

FIG. 9 b shows the device partially expelled from the sheath (notshown). The umbrella members 901 have opened and engaged the vesselwall, analogous to embodiments described previously. The oppositemembers are still in the closed form, restrained there by the sheath.FIG. 9 c shows the device completely expelled from the delivery sheath,where the opposite facing members 903 have curled or contracted. Sincethe opposite facing members are directly joined to the umbrella membersand have dominant memory characteristics, they force the umbrellamembers 901 to close. The opposite facing members are shown in figure aswire-like for ease of illustration; they can be configured as coiled orsemi-coiled structures, strut-like, multiple angles, spring-like, curledin an opposite direction, more than two members, elbow-like, or othergeometrical or curvolinear shapes that when extended are neutral to theumbrella members, but when expelled, dominate over the umbrella members,and force closure of the umbrella members, initiating puncture woundclosure.

Accordingly, the collarless double action vascular closure appositiondevice is first closed, then opens, and then closes again, with thesecond closure occurring spontaneously, by contraction of the oppositefacing members which have dominant memory characteristics over theumbrella members. The central junction can be loose enough (e.g., madeof a flexible polymer) to permit the forces from the contraction of theopposite facing members to be exerted on the umbrella members. In someembodiments each opposite facing member can be continuous with acorresponding umbrella member (i.e., a first portion of a single wirecomprises an umbrella member, a second portion of the same wirecomprising an opposite facing member). For simplicity, only two opposingmembers are shown in the figure; in embodiments where an umbrella memberand a opposite facing member are formed from a single wire, the numberof umbrella members can equal the number of opposite facing members, andeach opposing member-umbrella member can be an integrated piece ofmemory material. After the device has been delivered and vascularclosure is complete, then the guidewire can be removed.

In any of the embodiments described, the umbrella-like structure,members of this structure or components of the umbrella can be made fromany number of suitable materials, including radiopaque materials andmaterials coated to be made radiopaque, including bioabsorbable polymersor compounds, non-absorbable alloys and compounds including stainlesssteel, MP35, Nitinol, Nickel-Titanium ally, Kevlar, nylon polyesteracrylic, gold, platinum, tantalum, niobium, molybdenum, rhodium,palladium silver, hafnium, tungsten, iridium. Materials with memorywould also be preferable to allow the umbrella to spontaneously openafter placement by the sheath. These can be made in the form of wires,fibers, filaments, small beams, and other extruded, woven, or formedshapes. Piano wire, super elastic memory wire, chromium allows, alloysof titanium and nickel, and other elastic memory materials previouslymentioned as well as others can be used as well The umbrella fabric canbe made from a number of suitable materials, including flexiblepolymeric materials with elastomeric properties including polyurethane,polyethylene, polyestenurethane, polyimide, olyethreimide,polycarbonate, polysiloxane, polyvinyls, hydroxyethylmethacrylate,related polymers, co-polymers of these or other polymers, ordrug-embedded or drug-eluting polymers to prevent coagulation or intimalhyperplasia (such as Taxol), also which can be made radiopaque bymarkers and addition of appropriate radiopaque materials.

EXAMPLE EMBODIMENTS

The present invention can comprise a device to close puncture woundscaused by catheter procedures and especially angiography comprised of anexpandable umbrella-like device that in the compressed state resides ina sheath, and after being expelled from the sheath assumes a planar orconical or other shape, engages vessel wall by means of tissue hooks orpenetrators, is collapsed, analogous to umbrella tines, and brings theedges of the vessel wound or puncture into apposition. The device canhave a retaining locking device that prevents the umbrella-likestructure from reopening. This locking can be achieved by mechanicalmeans including deformable enlargements on the members, dentates,male-female connectors, peg and hole, or other directionalmating/locking devices on the members and retaining locking device. Thislocking device can have a washer like appearance, but can also take anumber of different forms, including an inverted umbrella device made ofmetal, plastic, composites, or biodegradable material.

The device can have single or multiple hooks and penetrating devices toengage and seize the vessel wall. Each hook can be a single or multiplehook. The device can have members (or tines) of the umbrella-likestructure that are linear, curvilinear, spiral, leaf-like, diamondshaped, woven, or other complex shapes, but still function as anopening-closing structure that can accommodate a retaining lock. Thedevice when expanded can have a planar or conical or reverse conicalgeometry, or other complex shape that can collapse into near-linear formwith traction and locking of the retaining lock. The device can have aretrieval fitting, usually a loop, fitted with a closed loop thread,string, or suture in order to apply traction to the device. The devicecan have a lumen for a guidewire.

The device can have members that are coated or backed with a fabric ormembrane, either completely or partially. The device can elutetherapeutic material to prevent thrombogenesis, hemorrhage,inflammation, and intimal hyperplasia with vascular closure. The devicecan be used in angiography, angioplasty, vascular puncture, tissuebiopsy, or trauma that cause a puncture wound that should be closed. Thedevice can comprise materials with memory, so that the devicespontaneously assumes it therapeutic shape when expelled from thesheath. The device can comprise at least 2 or more members; 3 or moremembers can be preferable in some applications. The device can havemembers with angled dentates or tissue penetrators to prevent movementor migration of the device into the lumen of the blood vessel. These canalso be used to retain the retaining lock.

A tissue opening can be closed according to the present invention by a)introducing a guidewire and sheath, b) penetrating the proximal surfaceof the blood vessel by the sheath and the guidewire, c) placing a devicein the closed form in the sheath, with the loop of string or suture, d)extruding the device from the sheath and expanding while in the tissue(e.g., while inside a blood vessel), e) pulling the device against thetissue wall (e.g., the blood vessel wall), seating the hooks in thetissue, f) partially removing the sheath is to seat the device while aretaining lock is advanced, g) advancing the retaining lock over themembers of the device while applying traction with the string, forcingthem in the closed position, h) bringing the edges of the puncture woundtogether; if no bleeding occurs, i) then removing the guidewire, j)cutting the loop of string, leaving the device safely seated and lockedwith the puncture repaired.

A tissue opening can be closed according to the present invention withsequential delivery of a device. For example, the following steps can betaken 1) first the guidewire and sheath are in place, 2) next theumbrella is pushed down the sheath, either next to the guidewire or withthe guidewire in the lumen of the umbrella; 3) the umbrella is extruded,and then using the thread or suture, pulled tight against the lumen ofthe vessel; 4) next the retaining lock is pushed down the thread and/orguidewire, and is pushed onto the umbrella while applying traction (thesheath can be removed partially at this stage, 5) after the retaininglock is seated, the sheath is observed for bleeding, 6) if there is nobleeding, then the sheath and guidewire are removed.

A tissue opening can be closed according to the present inventionemploying a dedicated device consisting of a sheath containing a device,a pushing device to push the device out (e.g., another sheath), a sheathto push the retaining lock, and a thread/suture to oppose the movementof the other sheaths and to retrieve the umbrella if it is misplaced.

The particular sizes and equipment discussed above are cited merely toillustrate particular embodiments of the invention. It is contemplatedthat the use of the invention may involve components having differentsizes and characteristics. It is intended that the scope of theinvention be defined by the claims appended hereto.

1) A tissue closure device, comprising: a) A junction body; b) Aplurality of tissue engagement elements, each having first and secondends, each mounted with the junction body near its first end in a mannerthat allows the tissue engagement elements to assume first and secondconfigurations, and each comprising a portion spaced from the first endadapted to engage the tissue in both the first and secondconfigurations, wherein: i) In the first configuration, the second endsof the tissue engagement elements are spaced from each other by at leasta first distance; ii) In the second configuration, the second ends ofthe tissue engagement elements are spaced from each other by no morethan a second distance, where the second distance is less than the firstdistance. 2) A tissue closure device, comprising a plurality of tissueengagement elements, mounted with each other such that in a firstcompressed configuration the tissue engagement elements can pass througha tissue opening to be closed, and such that in a second compressedconfiguration the tissue engagement elements bring the edges of theopening into apposition, and such that in an expanded configuration thetissue engagement elements span the opening, wherein the tissueengagement elements engage the tissue in both the compressedconfiguration and in the expanded configuration. 3) A device as in claim2, wherein the tissue engagement elements comprise hooks. 4) A device asin claim 2, wherein the tissue engagement elements comprise wires eachhaving a hook at a first end and slidably mounted with a lock device ata second end, wherein the wires assume the expanded configuration whennot constrained by the lock device and assume the compressedconfiguration when constrained by the lock device. 5) A device as inclaim 4, wherein the wires mount together at their second ends with astring receiving element adapted to engage a string such that tension onthe string opposed to force on the lock device urges the wires throughthe lock device substantially along the direction of the tension on thestring. 6) A tissue closure device, comprising: a) A junction element,having a string engagement portion; b) A plurality of members, whereeach member has a tissue engagement feature at a first end, and mountedwith the junction element such that the members extend away from thejunction element defining a truncated cone; c) A lock element comprisinga collar defining an interior passage, wherein passage of the junctionelement through the interior passage manipulates the members such thatthe area of the base of the truncated cone defined by the members isreduced. 7) A device as in claim 6, wherein the members comprise wireseach having a hook at its first end. 8) A device as in claim 6, whereinthe members comprise wires each having a plurality of hooks at its firstend. 9) A device as in claim 6, wherein the lock element comprises atissue engagement portion adapted to engage tissue over an area morethan three times the area of the interior passage. 10) A device as inclaim 6, wherein the junction element comprises a collar defining aninterior passage suitable for passage of a guidewire therethrough. 11) Adevice as in claim 6, wherein each member further comprises one or moresecondary tissue engagement features mounted with the member not at thefirst end. 12) A device as in claim 6, wherein the secondary tissueengagement members comprise projections from the member oriented towardthe first end. 13) A device as in claim 6, further comprising a coveringextending between the members. 14) A device as in claim 6, wherein thecovering comprises a therapeutic material eluted when the device isplaced in tissue. 15) A device as in claim 6, wherein the memberscomprise elongated diamond shaped elements. 16) A device as in claim 6,wherein the members are connected to each other by intermember struts.17) A tissue closure device, comprising: a) A junction element, having astring engagement portion; b) A plurality of members, where each memberhas a tissue engagement feature at a first end, and mounted with thejunction element such that the members extend away from the junctionelement defining a truncated cone, and having one or more secondarytissue engagement features mounted with the member and oriented towardthe first end. 18) A device to close openings in blood vesselscomprising an expandable umbrella-like device that in the compressedstate resides in a sheath; after being expelled from the sheath assumesa planar or conical shape; after being brought into contact with avessel wall engages the vessel wall; and can be collapsed to bring theedges of the opening into apposition. 19) A method of closing an openingin tissue, comprising: a) passing a device, as in claim 2, while in thefirst compressed condition through a sheath that penetrates the proximalsurface of the tissue; b) expelling the device from the sheath intospace beyond the proximal surface of the tissue such that the deviceassumes the expanded configuration; c) manipulating the device such thatthe tissue engagement elements engage the tissue; d) causing the deviceto assume the second compressed configuration, bringing the edges of theopening into apposition. 20) A method as in claim 19, further comprisingconfiguring the device such that it will remain in the second compressedconfiguration. 21) A method as in claim 19, wherein causing the deviceto assume the second compressed configuration comprises applyingtraction to the device. 22) A device as in claim 6, wherein the junctionelement defines a lumen suitable for passage of a guidewiretherethrough. 23) A device as in claim 2, wherein the tissue engagementelements comprise a shape memory material such that the tissueengagement elements assume the expanded configuration unless forced toanother configuration. 24) A method of as in claim 19, wherein: a) Thedevice comprises a string attachment portion, to which a string isattached; b) Manipulating the device such that the tissue engagementelements engage the tissue comprises pulling the string to encourage thedevice towards the tissue; c) Causing the device to assume the secondcompressed configuration comprises passing the string through a centralpassageway of a locking element, passing the locking element down thestring to the device, pulling the string such that a portion of thedevice engages the locking element, which engagement causes the deviceto assume the second compressed configuration. 25) A tissue closuredevice as in claim 2, wherein a) the tissue engagement elements compriseelongated members, where each elongated member defines a first portionand a second portion along the length of the member, and are mountedwith each other near the boundaries of the first and second portions ofthe members; b) each tissue engagement element is shaped such that,absent external restraining force, the first portion and second portionof the member form an angle less than 180 degrees to each other, and themounting of the tissue engagement elements is such that, when the firstportions of the members are substantially parallel to each other, thesecond portions extend approximately radially outward from the mounting,defining the expanded configuration; c) each tissue engagement elementcomprises a resilient material, such that the members can be forced to aconfiguration where the first portions of the members and the secondportions of the members can be contemporaneously contained within asheath, defining the compressed configuration.